The Hindu Business Line : Abbott's AIDS drug in a patent spot in India

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Mumbai Feb. 20 At the heart of a patent-related wrangle in Thailand, Kaletra - the AIDS-drug from the US drug-maker Abbott Laboratories seems to be in a patent spot in India as well. The patent application on the soft gel (SG) version of Kaletra seems to be "abandoned" at the Indian patent office.

The untimely closure on the Kaletra (SG) patent application comes even as the HIV-positive patient groups had filed pre-grant representations to oppose the grant of a patent on this drug by the Indian Patent Office.

Patient groups were told by the Patent office that the pre-grant representation had been disposed, as the patent application on the drug had been "abandoned" since the company had not responded to objections raised by the Patent office, a patent-lawyer familiar with the development told Business Line.

The drug

Kaletra is a combination of lopinavir and ritonavir and is used in the second line treatment of AIDS. In addition to the soft-gel version, Kaletra is also available more recently in a thermo-stable version, suitable for hot climates where refrigeration is not possible.

An Abbott spokesperson said: "For years Abbott has not marketed Kaletra SGC in India as there are numerous generics on the market. However, we plan to bring new formulations to market in India."

In India

Kaletra is sold in middle-income countries, as defined by the World Bank, at $2,200 per patient per year ($183 per month). Generic versions available in India are priced between $120-150 per month or $1,800 per year, an industry representative said. In India, Hetero, Cipla and Ranbaxy make generic versions of Kaletra (SG).

In Thailand

Kaletra was recently in the spotlight, when the Thailand Government threatened to break Abbott's patent on Kaletra by going in for a compulsory licence that would allow generic copies of the medicine, at lower prices. The Abbott spokesperson, however, pointed out that the developments in India and Thailand were unrelated.

Patent-related battles

AIDS drugs have been in the thick of patent-related battles in India, with patient-groups opposing patent applications on several AIDS drugs. Last year, GlaxoSmithKline withdrew its patent application on AIDS drug Combivir in Thailand and India.

International aid organisation Medicins Sans Frontieres' (MSF) Ms Leena Menghany pointed out that Kaletra was important as it had recently been included by the World Health Organisation in its treatment protocol. Though the heat-stable version would be useful in developing countries such as India, the drug has not been registered and is not available in India, she said.

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